1. Field of the Invention
The present invention relates generally to in-vitro diagnostic analyzers. Particularly, the present invention relates to in-vitro diagnostic analyzers and cartridge modules for use in urgent care, point-of-care and physician offices.
2. Description of the Prior Art
In-vitro diagnostic analyzers have been available for several decades. The market for these types of analyzers were typically for use in a central laboratory. The central laboratory was capable of testing for a wide variety of biomedical species typically in a patient's blood and/or blood plasma. Some of the tests were/are for key parameters associated with the treatment of diabetic patients.
Lately, there appears to be an on-going shift for such testing from central laboratory testing to point-of-care sites within a hospital. This shift provides for quicker test data results, which can be important in diagnosis and treatment of certain conditions. Point-of-care testing plays an important role in the management of critically ill patients and is widely used in the operating room, emergency room and intensive care units. These tests are no longer performed exclusively by skilled medical technologists but also by multiskilled personnel including nurses, respiratory therapists, emergency personnel, physicians, and other medical staff. To meet this demand, manufacturers have had to downsize the analyzers and simplify the test procedures so that only minimal training in performing the test procedures is required.
One key feature common to all point-of-care analyzers is that they must be either portable and/or transportable. Examples of such point-of-care analyzers include, but are not limited to, critical care analyzers from Roche Diagnostics, a division of Hoffman-La Roche, sold under the trademarks OPTI CCA and OMNI 9, critical care analyzers from Nova Biomedical Corporation sold under the trademarks STAT PROFILE ULTRA C and CRT, CRT from Nova Biomedical Corporation, and a critical care analyzer from Dade Berhing, Inc., a division of Siemens Healthcare Diagnostics, sold under the trademark DIMENSION RXL.
More recently, there is a further shift occurring to testing in a physician's office or laboratory located within a physician's office. As testing moves away from the central laboratory, new single use medical devices have been developed to meet this need.
In the physician's office environment, there are numerous devices that utilize a capillary to collect finger stick samples for analysis. The capillary may be either glass or plastic. Typical analyses are for species such as HbA1c, lipids, etc. Once the sample is collected, these capillary-based collection devices are loaded into an analytical cartridge, which is then loaded into an instrument for analysis.